quala topical anesthetic gel

Generic: benzocaine

Labeler: mycone dental supply co., inc dba keystone industries and deepak products inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name quala topical anesthetic gel
Generic Name benzocaine
Labeler mycone dental supply co., inc dba keystone industries and deepak products inc.
Dosage Form GEL
Routes
DENTAL
Active Ingredients

benzocaine 200 mg/g

Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

Identifiers & Regulatory

Product NDC 68400-475
Product ID 68400-475_2bd99a1b-e6db-0724-e063-6294a90a2671
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2022-02-03

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68400475
Hyphenated Format 68400-475

Supplemental Identifiers

RxCUI
238910
UNII
U3RSY48JW5
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name quala topical anesthetic gel (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
source: ndc
Packaging
  • 30 g in 1 JAR (68400-475-30)
source: ndc

Packages (1)

68400-475-30 30 g in 1 JAR (68400-475-30)

Ingredients (1)

benzocaine (200 mg/g)

Linked Drug Pages (1)

Quala Topical Anesthetic Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "2bd99a1b-e6db-0724-e063-6294a90a2671", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["238910"], "spl_set_id": ["d721864d-0950-8379-e053-2a95a90a3bcb"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 JAR (68400-475-30)", "package_ndc": "68400-475-30", "marketing_start_date": "20220203"}], "brand_name": "Quala Topical Anesthetic Gel", "product_id": "68400-475_2bd99a1b-e6db-0724-e063-6294a90a2671", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "68400-475", "generic_name": "Benzocaine", "labeler_name": "Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Quala Topical Anesthetic Gel", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220203", "listing_expiration_date": "20261231"}